An increasing number of materials sold on the market today are sensitive to contamination by viable microorganisms. Drugs that are injected into living tissue or blood (parenteral solutions) are particularly sensitive to contamination by such microorganisms. The current standard set by the U.S. Food and Drug Administration (FDA) regarding the probability of having a viable microorganism present in an aseptically-assembled product is generally on the order of one in one thousand (10.sup..times.3). The FDA would like to increase this standard to one in one million (10.sup..times.6). Consequently, the FDA is encouraging change in parenteral drug manufacturing that will decrease the probability of contamination.
There are several paths available to decreasing the probability of viable microorganisms in a parenteral drug product. One of these paths which is encouraged by the FDA is the use of terminal sterilization where possible for parenteral-type pharmaceutical products. Many such products, however, are temperature sensitive, i.e., a temperature that is significantly greater than ambient temperatures will rapidly degrade their efficacy or activity. For products that cannot be terminally sterilized, improved aseptic manufacturing systems are the only alternative.
One method of controlling the contamination of parenteral drug products involves sterilizing the products prior to filling. The products are then aseptically filled and the containers closed within a decontaminated box that is absent of any workers. Such a system has the potential of meeting the reduced microbial contamination levels sought by the FDA. This type of system is called a barrier system since there is a barrier between the product and the equipment operator.
For a barrier system to help meet the new FDA objectives, it must have isolation integrity and be able to maintain this isolation integrity during operation. The decontamination of barrier systems is a critical part of the process. A variety of techniques are known in the art for effectively decontaminating filling lines and the like which are used in connection with pharmaceutical products. Chemicals may be used for this decontamination, but they are hazardous and can leave residue. Any active molecule that has the potential to come into contact with a sensitive product can potentially degrade or contaminate that product. Accordingly, an effective means of decontaminating the equipment inside the barrier that only utilizes temperature and environmental conditions that will not adversely affect the equipment or its component parts should speed this needed development.
To avoid degrading the efficacy of a pharmaceutical product by overheating, however, elevated-temperature decontamination generally must be carried out when the equipment is not being used to handle the product. Unfortunately, this essentially represents "down time"for these pieces of equipment, preventing them from performing their intended function during the decontamination process. Accordingly, it would be desirable to provide a system for decontamination equipment used for handling biologically sensitive products which achieves a high level of decontamination with a minimum of down time for the equipment.